Pharmaceuticals

We have a track record of success in navigating the drug development regulatory landscape. Our services include:

Study Design and Oversight

Regulatory Filings

  • Toxicology

  • Create and Review SOPs

  • Pharmacology

  • Clinical Trials (I-IV)

  • Investigational New Drug Application (IND)

  • 505(b)(1) New Drug Application (NDA), 505(b)(2) NDA, 505(j) Abbreviated New Drug Application (ANDA)

  • Combination Products

  • Drug Master Files

Compliance Planning and Strategy

 

Manuscript and Report Writing

 

Scientific and Regulatory Due Diligence Assessments